Single use systems, also called disposable systems are more and more used in the bioprocess industry. For example separation or reaction systems such as chromatography systems, filter systems or bioreactor systems have today at least partly been provided as disposable systems. This eliminates the need for cleaning and cleaning validation before processing, in between processes and cycles or after processing before re-use as required for conventional re-usable equipment. With disposable systems cross-contamination is avoided.
Bioburden control of single-use equipment during manufacturing of the equipment itself is required to eliminate cleaning needs before bringing single-use equipment into product contact. This is usually achieved by manufacturing of single-use equipment in controlled environment (clean room), often followed by sterilisation processes (gamma irradiation). The demands of the level of bioburden control can differ for different applications, however, bioburden control to a certain degree of the equipment is not only required for some applications, but also considered as the preferable for most of the applications using disposable equipment. The production of this equipment in controlled environments is required to guarantee a low initial level of contaminants prior to the bioburden control procedure, hereby reducing for example endotoxin levels. Sterility and asepsis are terms used to define the state of a system, a piece of equipment or a fluid conduit as being in control of bioburden levels to different degrees.
Aseptic connectors can be used to interconnect single-use equipment and also single-use equipment and conventional re-use equipment that is bioburden controlled (santized, sterilised etc.). Available aseptic connectors are for example ReadyMate connectors from GE Healthcare and Kleenpack from Pall.
Typical applications of aseptic connectors in biomanufacturing are connections between fluid lines, separation units (filters, chromatography columns, adsorbers, membrane adsorbers, expanded or fluidized bed adsorbers) or reaction units (bioreactors, reaction or (bio-)conversion units that for example utilize enzymatic conversions).
An example of a disposable separation system built up from a number of units is described in US20070241048. A problem with this system is that in order to maintain asepsis (or bioburden control) at process side when assembling the unit, assembly has to be done in a controlled environement (LAF bench).
A possible solution with today available technique is to connect each separate disposable separation or reaction unit with aseptic connectors. However this is not cost efficient and separation efficiency is reduced due to high hold-up volume in interconnecting fluid lines.
Hereby, disposable separation or reaction systems available today are not flexible when it comes to the capacity of the system.